BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MAGNA-ROM 21 KNEE SYSTEEM

    K Number: K991143 · Decision Jun 11, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    910
    Applicant Total
    45
    Review Days
    67

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    Basic Information

    Device Name
    MAGNA-ROM 21 KNEE SYSTEEM
    K Number
    K991143
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sulzer Orthopedics, Inc.
    Date Received
    April 5, 1999
    Decision Date
    June 11, 1999
    Product Code
    JWH
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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    Other Clearances by Sulzer Orthopedics, Inc.

    K Number Device Name
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    K013935 ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
    K013031 MOST OPTIONS SYSTEM
    K012739 CONVERGE ACETABULAR SYSTEM
    K012961 SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
    K011954 SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
    K010839 CLS VARUS STEM/CLS 135 STEM
    K003758 ALLOFIT ACETABULAR SYSTEM
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